CCI-779 in Treating Patients With Extensive-Stage Small Cell Lung Cancer

Extensive Stage Small Cell Lung Cancer Clinical Trial

Official title: A Randomized, Phase II ECOG Trial of Two Dose Levels of CCI-779 in Patients With Extensive-Stage Small Cell Lung Cancer Who Have Responding or Stable Disease After Induction Chemotherapy

Status Completed

Clinical Trial Summary

Randomized phase II trial to compare the effectiveness of different doses of CCI-779 in treating patients who have extensive-stage small cell lung cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To study the progression-free survival in patients who receive a lower or a higher dose of CCI-779, a cytostatic agent following cytoreductive chemotherapy in extensive SCLC.

II. To determine the toxicity of two treatment regimens involving a lower or a higher dose of CCI-779.

SECONDARY OBJECTIVES:

I. To quantify the effects of CCI-779 treatment on p70S6 phosphorylation in peripheral blood mononuclear cells of patients with small cell lung cancer who are treated with CCI-779.

II. To measure the effects on mTOR activation and signaling of plasma from patients treated with CCI-779.

III. To determine the relationship between CCI-779 dose and its pharmacodynamic parameters.

IV. To correlate the inhibition of p70S6 with indices of patient outcome.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to brain metastases (yes vs no), prior induction chemotherapy regimen (platinum and etoposide vs platinum and irinotecan), and response to prior induction chemotherapy (complete or partial response vs stable disease). Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive low-dose CCI-779 IV over 30 minutes once weekly. Treatment continues in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive high-dose CCI-779 as in arm I.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Extensive Stage Small Cell Lung Cancer
• Lung Neoplasms
• Small Cell Lung Carcinoma

• NCT number: NCT00028028
• Study type: Interventional
• Source: National Cancer Institute (NCI)
• Status: Completed
• Phase: Phase 2
• Start date: February 2002